P3 Study in Acne Comparing Once Daily SB204 and Vehicle

A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: SB204 4%; Drug: Vehicle Gel

Detailed Description

This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

• Study Type: Interventional
• Enrollment (Actual): 1307
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CIL #146
    • Encinitas, California, United States, 92024
      • CIL #118
    • Fresno, California, United States, 93720
      • CIL #186
    • Fresno, California, United States, 93720
      • CIL #210
    • Oceanside, California, United States, 92056
      • CIL #209
    • San Diego, California, United States, 92103
      • CIL #161
    • San Diego, California, United States, 92123
      • CIL #113
    • Santa Rosa, California, United States, 95405
      • CIL #199
  • Florida
    • Boca Raton, Florida, United States, 33486
      • CIL #103
    • Hialeah, Florida, United States, 33012
      • CIL #173
    • Homestead, Florida, United States, 33030
      • CIL #212
    • Lauderdale Lakes, Florida, United States, 33406
      • CIL #222
    • Miami, Florida, United States, 33144
      • CIL #157
    • North Miami Beach, Florida, United States, 33162
      • CIL #177
    • Orlando, Florida, United States, 32814
      • CIL #172
    • Orlando, Florida, United States, 32801
      • CIL #150
    • Ormond Beach, Florida, United States, 32174
      • CIL #203
    • South Miami, Florida, United States, 33413
      • CIL #211
    • Tampa, Florida, United States, 33609
      • CIL #229
    • Wellington, Florida, United States, 33414
      • CIL #153
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Cil # 179
  • Kansas
    • Wichita, Kansas, United States, 67207
      • CIL #215
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • CIL #117
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • CIL #180
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • CIL #205
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • CIL #230
  • Michigan
    • Detroit, Michigan, United States, 48183
      • CIL #112
    • Troy, Michigan, United States, 48084
      • CIL #149
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • CIL #225
    • Saint Louis, Missouri, United States, 63141
      • CIL #187
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • CIL #140
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • CIL #182
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • CIL #201
    • Montclair, New Jersey, United States, 07042
      • CIL #141
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • CIL #156
  • New York
    • New York, New York, United States, 10155
      • CIL #107
    • Rochester, New York, United States, 14623
      • CIL #108
    • Stony Brook, New York, United States, 11790
      • CIL #104
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • CIL #193
    • Winston-Salem, North Carolina, United States, 27103
      • CIL #166
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • CIL #226
  • Oregon
    • Portland, Oregon, United States, 97210
      • CIL #200
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • CIL #236
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • CIL #217
  • Texas
    • Arlington, Texas, United States, 76011
      • CIL #198
    • Beaumont, Texas, United States, 77701
      • CIL #154
    • Carrollton, Texas, United States, 75010
      • CIL #162
    • Houston, Texas, United States, 77055
      • CIL #188
    • Plano, Texas, United States, 75093
      • CIL #151
    • Plano, Texas, United States, 75234
      • CIL #168
    • San Antonio, Texas, United States, 78218
      • CIL #224
    • San Antonio, Texas, United States, 78229
      • CIL #171
    • Sugar Land, Texas, United States, 77479
      • CIL #164
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • CIL #106
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • CIL #114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate to severe acne
• Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
• Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion Criteria:

• Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
• Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB204 4%; SB204 4% topically once daily	Drug: SB204 4%; Once daily; Other Names: NVN1000
Placebo Comparator: Vehicle Gel; Vehicle Gel topically once daily	Drug: Vehicle Gel; Placebo comparator; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Inflammatory Lesion Counts	The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.	Baseline and Week 12
Absolute Change From Baseline in Non-inflammatory Lesion Counts	The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).	Baseline and Week 12
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.; Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).; Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.; Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.; Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Inflammatory Lesion Count	The percent change from baseline in inflammatory lesion count	Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count	The percent change from baseline in non-inflammatory lesion count	Baseline and Week 12
Time to Reduction in Inflammatory Lesion Counts	Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)	Week 12
Time to Improvement in IGA	Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).	Week 12

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: Chiltern International Inc.
• Investigators: Study Chair: Joyce Rico, MD, Novan, Inc.

Publications and helpful links

Helpful Links

• Study specific web site

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 21, 2016

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimated): February 3, 2016

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO